How To Set An Import Tolerance

Import tolerance setting in the EU

Residues Workshop

Brussels, 26

_-27

_January

Euros Jones

Import tolerance

Ø MRL set for imported products where:

-  the use of the active substance is not authorised in

the EU, or

-  a different level is appropriate for the specific product

and specific use;

What is the view of ECPA and the CP industry?

Ø To set EU MRLs where possible – and to ensure the

availability of products and crop uses for European farmers

Ø Only when an EU MRL is not needed or not possible,

to set import tolerances to allow trade

Ø  Reduce the risk of trade distortion – which also requires the EU to move back to a risk assessment process for plant protection products.

Two procedural issues of concern that could

impact trade:

1. Import tolerances for substances not

authorised in the EU

2. Procedure delaying the setting of import

tolerances

There are also other practical concerns – these are not covered in this presentation…

New challenges in setting

import tolerance

Import tolerances

Numerous examples where active substances are not authorised in the EU but are important in third countries

The application of cut-off criteria has raised questions about the future setting of import tolerances

This is an issue that is still under discussion in DG SANTE

Import tolerances for substances

not authorised in the EU

Import Tolerances (ITs)

Question: If an AS is ‘cut-off’ by the EU legislation, can

Commission set an import tolerance for third country trade?

Commission legal view?:

Ø Both interpretations possible for substances captured

by ED and other cut-off criteria

Ø  Both positions likely to be challenged!

•  Legal advice opens the way for a political decision by the

Commission

Key considerations:

Import tolerance setting under Regulation

396/2005 should be based on a consumer risk

assessment!

Implementing a hazard based evaluation for

import tolerances would raise questions

Legality?

Impact on trade…?

Import tolerances for substances

not authorised in the EU

Regulation 1107/2009 required criteria by end-2013

• Assessment still on-going…

Public consultation

•  Ended on 16 January 2015

Impact assessment being carried out

•  Assessment of impact on individual substances (2015)

•  Agronomic & Socio-economic impact (2016)

•  Criteria to be proposed in late 2016

External assessment on trade impact in 2013…

Helping  Farmers  Grow  

Helping  Farmers  Grow  

Globally, €65 billion of EU imports potentially affected by ED cut-off criteria

Impact on Trade

€ 8.4 billion

€ 6.9 billion

€ 6.9 billion

€ 24.3 billion

€ 7.9 billion

Category €m (2012)

Fruit and Nuts € 13,795

Animal Feed Ingredients

€ 9,780

Oilseeds and Groundnuts

€ 9,574

Coffee, Tea and Spices

€ 9,470

Vegetable Oil € 8,222

Cereals € 4,613

Cocoa € 4,336

Vegetables € 3,525

Sugar € 2,046

Total € 65,362

The setting of import tolerances should be based on

a robust risk assessment process

System needs to be :

–  Compatible with international commitments (SPS)

–  Predictable to support trade

Hazard based cut-off criteria should not impede the

import tolerance process

–  Avoid possible distortion –requires a risk (not hazard)

based system for product authorisation in EU

Import tolerances for substances

not authorised in the EU

Import tolerances

Industry has traditionally applied for import

tolerances in parallel to product/use applications

in third countries

–  Aim is to have EU import tolerance by the time the

product is authorised (in EU and in third countries!)

EFSA view is they do not want to evaluate until

authorisations are in place in third countries

–  This is very different to the EU procedure where MRL is

needed before products are authorised!!

…

import tolerance requests should not be

evaluated neither by the evaluating Member

State, nor by EFSA until:

–

evidence has been provided that the respective

use is authorised in the exporting country and

–

that the MRL proposed as an import tolerance is

not higher than the one established in the country

of origin.

Commission letter on setting

new import tolerances

Ex.: Product authorised in third country in

January 2015

Product used in March 2015

–  Crop exported to EU in May 2015

IT application in February 2015

–  MS evaluation in 4 months (June 2015)

–  EFSA evaluation in 4 months (October 2015)

–  Standing Committee vote in 3 months (January 2016)

–  Comitology in 3 months (April 2016)

–  Publication of IT - May 2016

–

POTENTIAL FOR MAJOR TRADE IMPACT!

Impact on new import tolerances

Ex.: Product authorised in third country in

January 2015

Product used in March 2015

–  Crop exported to EU in May 2015

IT application in February 2015

–  MS evaluation in 4 months (June 2015)

–  EFSA evaluation in 4 months (October 2015)

–  Standing Committee vote in 3 months (January 2016)

–  Comitology in 3 months (April 2016)

–  Publication of IT - May 2016

–

POTENTIAL FOR MAJOR TRADE IMPACT!

Impact on new import tolerances

>> 1 year later

–  Crop exported to EU in May 2015

IT application in February 2015 (Current timelines)

–  MS evaluation in 11 months (January 2016)

–  EFSA evaluation in 6 months (July 2016)

–  Standing Committee vote in 4 months (Nov 2016)

–  Comitology in 3 months (Feb 2017)

Need to highlight potential impact on trade

–  Potential impact on residue monitoring results as well!!

Need to ensure a system that will allow timely

setting of import tolerances

Impact on new import tolerances

Working together

Conclusions

Ø

Industry

’

s aim is to set EU MRLs where possible –

and to ensure the availability of products and crop

uses for European farmers

Ø

Where separate import tolerances are needed, an

efficient risk based process is needed to minimise

trade disruption and residue exceedences.

Ø

Distortion of competition a concern –return to risk

based system would be best!